Duns Number:311231554
Device Description: "Keypoint Focus ModuleIncluding:- Keypoint Focus main unit with control panel, integrated "Keypoint Focus ModuleIncluding:- Keypoint Focus main unit with control panel, integrated speakers, EP stimulators- Module kit including Keypoint software CD"
Catalog Number
-
Brand Name
Alpine BioMed
Version/Model Number
9033A0701
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 28, 2020
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K944547
Product Code
GWF
Product Code Name
Stimulator, Electrical, Evoked Response
Public Device Record Key
371eeb58-c10d-40cc-9911-25b84ba33599
Public Version Date
April 29, 2020
Public Version Number
4
DI Record Publish Date
August 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 191 |